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ARRY- I think you are right about what will happen to the marketcap. Since this is a P 1 program the 60 M may not substantially increase the MC though I think 50% is nothing to be ashamed about. If any of the P II programs get partnered that would really give it a shot.
MDVN did the same for the Astellas deal. I assume it will be positive.
ARRY - Has an option to co-promote the drug. The company now has about 130 million in cash and around 120 M in debt (??) and if it opens at around 3 tomorrow will have a MC of around 150 million. It definitely appears to be a much better investment now assuming more partnerships are around the corner. I like the fact that MGMT delivered on schedule. Still waiting for ARYX management to complete a Budiodarone deal that was supposed to be done 6 months ago.
I'm just repeating what was said by Roche during the call. Just doesn't make sense why the FDA wouldn't want to approve but Roche being so tentative is somewhat telling. Do you remember why they didn't have an SPA for this in the first place?
SUPG - The OI is around 220. That seems to imply that options were bought back to close existing positions which is still positive.
Someone just asked the question during the Roche call. IT appears that Roche will not commit to a filing until the FDA meeting since the FDA prefers randomized trials. My guess is that this is Roche being careful with the FDA but maybe p3analyze is correct.
Highly unlikely that ARIA will run a trial (if any) on its own. It may be worthwhile to partner it even for a paltry terms so it would be foolish of Berger to not put any positive spin on the data. I don't see any downside to Berger hyping the data.
That does prove you are probably correct. However I am curious why they wouldn't file. I don't entirely buy the theory that it could skew 1st line or 2nd line trials.
imgn -
It appears that Roche is not in a hurry to file for 3rd line.
ONce T-DM1 is approved, those patients randomized to control arm would be clamoring for it upon disease progression.
Ameritrade does. You don't have to have an account. Got to ameritrade.com and enter the symbol and it shows the the updated shares outstanding.
ARIA - I agree that the results aren't too impressive. It appears based on the poster though that further studies are warranted. The silence from the company on the trial results is deafening.
ARIA - Poster for Rida in BC
http://www.posters2view.com/sabcs09/viewp.php?nu=3091
SNSS - Here's the reason.
Sunesis Pharma shares up for 2nd day on data, partnership talks
By Vidya L Nathan
Cowen & Co analyst Craig Gordon attributed the gains on Thursday and Friday to investors speculating about a possible partnership on the drug and the positive data.
"If you ask me for percentages, I think 60 percent to 70 percent of the spike is on the chances of a partnership and 30 percent to 40 percent is from the data," Gordon said.
Sunesis Pharmaceuticals' Chief Financial Officer Eric Bjerkholt told Reuters that the company was already in talks for a partnership.
We're exploring alternatives for funding for that (late-stage) trial, and partnerships is one of the alternatives that are being explored, Bjerkholt said.
"And then, yes, the last alternative might be to sell the company," he added. Bjerkholt said he would not be able to comment on which option the company would prefer until the terms on the funding alternatives were available. Sunesis, which has $3.9 million in cash and marketable securities as of Sept 30, is already in talks with possible partners on the drug, or buyers.
The CFO denied commenting if the deal talks were with buyers or with potential partners.
"One of the reasons we are attracted to discussing with partners is that there is a broader development plan than we could possible fund on our own," Bjerkholt said.
Cowen & Co's Gordon sees an upfront payment of between $50 million to $70 million on the drug, but does not rule out a possible acquisition of the company.
"So with a partnership we can have a joint development plan that could hopefully include other indications," he added.
What is causing the upwards movement in all these stocks in your opinion? Is it funds accumulating to become long and then retail investors and traders tagging along or simply manipulation?
SNSS - Unbelievable action and I am lucky I decided not to short. Very similar to SOMX a few months ago.
OT - Coffee
Prostate cancer or drinking vile, over-roasted swill
SNSS vs CYCC - I don't disagree with any of your points. My guess is this is manipulation on a grand scale. I've never shorted a stock before but I'm tempted.
SNSS - I think if you convert the preferred and warrants to common the marketcap is fairly close to 300 M.
SNSS - They recently did two financing deals and this may be manipulation for the warrants to be sold. Whatever shares I had I sold when the price spiked to .70. Too bad!
http://finance.yahoo.com/news/Sunesis-Pharmaceuticals-prnews-3143456795.html?x=0&.v=1
OT - Once SBUX comes in to the k cup market VH will probably be gobbled up by one of them and then it'll just be GMCR and SBUX.
PARD - Short interest is 51%. Never seen anything like that.
IMGN - Abstract
Abstract 710
A phase 2 study of trastuzumab-dm 1 (t-dm 1), a novel her 2 antibody–drug conjugate, in her 2+ metastatic breast cancer (mbc )
patients previously treated with conventional chemotherapy, lapatinib and trastuzumab
Ian Krop, Dana Farber Cancer Institute, Boston, MA; Patricia LoRusso, Karmanos Cancer Institute, Detroit, MI; Kathy D. Miller,
Indiana University Melvin-Bren Simon Cancer Center, Indianapolis, IN; Shanu Modi, Memorial Sloan-Kettering Cancer Center, New
York, NY; Denise Yardley, Sarah Cannon Research Institute, Nashville, TN; George Rodriguez, South Texas Oncology/Hematology,
San Antonio, TX; Sam Agresta, BioOncology, Genentech, South San Francisco, CA; Maoxia Zheng, BioOncology, Genentech, South
San Francisco, CA; Lukas Amler, BioOncology, Genentech, South San Francisco, CA; Hope Rugo, UCSF Comprehensive Cancer
Center, San Francisco, CA
Background: T-DM1 combines the HER2-inhibiting properties of trastuzumab with targeted delivery of the anti-microtubule
agent DM1. In a prior phase 2 study, single agent T-DM1 was well tolerated and had significant activity (objective response rate
[ORR] of 26% by independent review [IRF]) in 112 patients (pts) with pre-treated HER2+ MBC (Vogel CL et al, J Clin Oncol, 27:15s,
2009 [suppl; abstr 1017]). To confirm and extend these findings, we conducted a phase 2 study that enrolled a more homogenous
population of HER2+ MBC pts who had all received prior anthracycline, taxane, capecitabine, trastuzumab, and lapatinib therapy
and progressed on the last regimen received (at least 2 HER2-directed regimens had to be given for metastatic disease).
Methods: This is an open-label, single-arm study of T-DM1 given at 3.6 mg/kg IV q3w. Primary objectives are to assess ORR by
IRF and evaluate the safety of T-DM1. Key secondary objectives assess the clinical benefit rate (CBR = ORR + stable disease [SD]
at 6 months), duration of response (DoR) and progression-free survival (PFS). Pts remain on study until disease progression
or unmanageable toxicity. Key exploratory objectives were the assessment of ORR and clinical benefit rate (CBR) by IRF in
retrospectively tested, centrally confirmed HER2+ patients.
Results: The study completed enrollment of 110 patients. This analysis has a median follow-up of 8.3 months (range 0.7-13.1).
Median age was 52.5 y (range 34–77). Pts received a median of 7 agents for metastatic disease (range 1–15). Median
durations of prior trastuzumab and lapatinib treatment in metastatic setting were 19.4 and 6.9 months respectively. The
ORR was 32.7% and the CBR was 44.5% by IRF. Median DoR and PFS have not reached maturity. In retrospectively tested,
centrally confirmed HER2+ patients, the ORR was 39.5% and the CBR was 52.6% by IRF. T-DM1 was well tolerated, with no
dose-limiting cardiotoxicity. One pt with pre-existing non-alcoholic fatty liver disease died with hepatic dysfunction. The
most common adverse events were fatigue (59.1% of pts), nausea (37.3%), and thrombocytopenia (29.1%); 41.8% of pts
experienced at least one grade 3 or above adverse event.
Conclusions: In this study, single agent T-DM1 demonstrates a 32.7% ORR with an acceptable safety profile in a well defined,
homogeneous, and extensively pretreated population that has not been previously studied. Centrally confirmed HER2 positivity
strongly correlated with objective response. These results confirm the activity of T-DM1 in treatment resistant HER2+ MBC. An
ongoing global randomized phase 23 study is evaluating T-DM1 compared with lapatinib plus capecitabine in pts with advanced
HER2+ who have been previously treated with a taxane and trastuzumab.
http://sabcs.org/Newsletter/Docs/SABCS_2009_Issue1.pdf
SNSS - is up 150% for no apparent reason.
IMGN - This is probably the reason for the weakness today. Filing for third line may depend on discussions with FDA on whether the data is good enough.
When was the last time FDA approved on single-arm ORR?
IMGN - Jbog just saw the 8K. That seems much better than expected and I'm surprised that the reaction is muted. This should be good enough to file for 3rd line.
IMGN - TDM1 will be a poster presentation as opposed to an oral one. Debating on the relevance of that.
http://www.roche.com/media/media_releases/med-cor-2009-12-09.htm
ARIA - I think in July Berger gave a November timeline for a 534 partnership. So a deal is likely to be done before 2nd interim results. BTW even if the 2nd interim is not +ve if a deal is not done by then the stock is unlikely to crater until final results.
NBIX - Thanks for posting the notes. I was looking into getting into NBIX. Was it stated during the CC that the December PII endpoints will not be accepted by the FDA. I am curious why they are even burning much needed cash on this trial then.
ARIA - I am still a bit sketchy about the market potential for Sarcoma but assuming ARIA is able to garner a deal for 534 in the 75-100 million range it seems to me that the worst that could happen if the Sarcoma trial fails is that the marketcap will fall down to around 200-250 million which is close to what the MC is right now. ARIA is not a binary in the same fold as ACAD or PARD which were true binary stocks.
DDRX
ARIA IMGN - I am invested in IMGN as well but I think at this point TDM1 is likely to be a 3rd line treatment only to be used in patients who progressed on Tykerb. The jury is still out on Rida. However the fact that the PII Rida trial does not have a comparator arm is a negative IMO. Even if the results are positive there is nothing to compare with. TDM1 had less efficacy in terms of PFS in the trial with Tykerb.
ARIA - MRK made its decision about 5 months ago. The trial still hasn't been enrolled fully. Do you think MRK was able to make a decision on efficacy based on preliminary results in July? There could still be some value in that indication though MRK backing out without waiting an additional few months makes me agree with your sentiment.
Thats a valid point. They are presenting on a CTCL trial tomorrow and there are a couple of presentations going on tonight as well. Lets see what happens.
ARIA - They are also expected to present the PII updated breast cancer results in San Antonio. May get a bigger bump from that.
ALTH - Lost about 15% on this announcement in the afternoon and I decided to enter a small position. Based on what I can see, even if Istodax succeeds in PTCL, Folotyn appears to have a much better safety profile and also can be administered easier and CELG's acquisition appears to reinforce the market value in PTCL and CTCL.
SNSS - Sunesis Presents Positive Phase 2 Clinical Data of Voreloxin in Acute Myeloid Leukemia at the American Society of Hematology 2009 Annual Meeting
Conference Call Scheduled for December 8 at 2:00 PM EST to Discuss ASH Data Presentations
SOUTH SAN FRANCISCO, CA--(Marketwire - 12/07/09) - Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS - News) today announced positive data from two Phase 2 clinical trials of the Company's lead drug candidate, voreloxin. The results highlight voreloxin's strong efficacy and safety profile when used as a single agent or in combination with chemotherapy in patients with difficult to treat acute myeloid leukemia (AML). The trial results were presented at the 51st American Society Hematology (ASH) Annual Meeting in New Orleans, LA. The presentations are available on the Sunesis website at www.sunesis.com.
"These results provide us with the efficacy and safety data to move voreloxin forward into pivotal testing," said Steven Ketchum, Ph.D., Senior Vice President of Research and Development at Sunesis. "Trial results show that the high rates of remission observed in both trials have translated into durable effects with meaningful preliminary overall survival results. With an anticipated median survival of three and a half to six months on currently available therapies, primary refractory and first relapse AML patients are particularly in desperate need of more effective treatment options. We look forward to discussing these data with the FDA in our End-of-Phase 2 meeting scheduled for the first quarter of 2010."
Phase 1b/2 Clinical Trial of Voreloxin in Combination with Cytarabine in Relapsed/Refractory (Abstract No. 645)
In an oral presentation, Jeffrey Lancet, M.D., Associate Member, Section Chief - Leukemia, Department of Hematologic Malignancies, at the H. Lee Moffitt Cancer Center & Research Institute and a clinical trial investigator, presented data from a Phase 1b/2 clinical trial testing voreloxin in combination with cytarabine, a widely used chemotherapy, in patients with relapsed or refractory AML. The trial is designed to evaluate the safety, pharmacokinetics and anti-leukemic activity of escalating doses of voreloxin when administered in combination with cytarabine given either as continuous infusion or as a two hour IV infusion. To date, 66 patients have been treated in the expansion Phase 2 populations of the trial, which includes primary refractory and first relapse AML patients. Of these, 64 patients were evaluable for efficacy outcomes.
Among evaluable first relapse (n=36) and primary refractory patients (n=28), preliminary median overall survival is 7.8 months and the remission rate is 31% (complete remission [CR] 27%, complete remission without full platelet recovery [CRp] 2% and complete remission with incomplete recovery [CRi] 2%). Historical median overall survival data in primary refractory and first relapse patients on currently available chemotherapies range from 3.4 to 5.9 months(1) (2).
Voreloxin in combination with either bolus or continuous infusion cytarabine was generally well-tolerated. Infection-related toxicities were the most common Grade 3 or higher non-hematologic adverse events. In addition, Grade 3 or higher oral mucositis was observed.
All-cause mortality among these patients was 1% at 30 days and 8% at 60 days.
A recommended pivotal dose-regimen of voreloxin used in combination with cytarabine has been identified.
"Voreloxin has induced remissions in difficult to treat relapsed, primary refractory and relapsed/refractory AML patients," said Dr. Lancet. "Voreloxin used in combination with cytarabine has demonstrated meaningful anti-leukemic activity with an acceptable tolerability profile in these difficult-to-treat patients."
http://finance.yahoo.com/news/Sunesis-Presents-Positive-iw-3142073650.html?x=0&.v=1
SOMX - I'm surprised it has held up so well considering its trading around x6 cash after the CRL. They may want to hire VNDA's "consultant".
CYCC -
The next big event for the company is FDA guidance on the pivotal Phase 3 trials.
CYCC - ARM B for AML showing lower ORR and 1 yr survival than A seems counter intuitive given that it was a higher dose than A.